A multicenter, randomised, double-blind, placebo-controlled phase IIIb study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure patients (CRLXA).
To demonstrate that serelaxin is superior to placebo in reducing cardiovascular death in acute heart failure patients during a follow-up period of 180 days.
A randomised, double blind, placebo-controlled trial.
Metra Marco and Teerlink John for the RLX030A2301
Dr Alasdair Gray
Dr Martin Denvir – Co PI
Dr James Dear – Co PI
Dr Kristin Haga – Investigator
Dr Alastair Moss – Investigator
Polly Black – Research Nurse
Kirsty Simpson – Research Nurse
Rachel O’Brien – Research Nurse
Julia Grahamslaw – Research Nurse
Patients who are admitted to hospital with acute heart failure, who have received IV diuretics and have a degree of impaired renal function.
Honorary Professor of Emergency Medicine & Clinical Director of the Emergency Department
People who develop an Acute Kidney Injury (AKI) often have a poor prognosis and many go on to develop chronic kidney disease (CKD). The recognition that AKI and CKD are linked is recent and the molecular pathways that control the transition from acute injury to chronic disease are not well defined. Currently there are no specific treatments that reduce the risk of progressing to CKD after AKI.
Preliminary investigations (not yet published) suggest that AKI causes sustained activation of the endothelin (ET) system to the long-term detriment of renal and systemic haemodynamic function. These pilot data form the basis of our project that seeks to determine whether the ET system is active in patients with AKI and, thus, represents a potential target for therapeutic intervention.
KRAKIL aims to recruit altogether 100 patients from across the emergency department, acute medical unit and inpatient wards at the Royal Infirmary. 50 of which with AKI’s and 50 matched controls with normal kidney function. We will monitor their bloods and urine for 90 days and compare the data from between the two groups.
Assisting in identifying patients with Humeral shaft fractures in the ED by screening.
Giving patient information sheets to introduce the study, so patient has had adequate time to read and make decision about going into the trial before going to the fracture clinic.
ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections in the UK (CCP-UK)